Deputy Qualified Person for Pharmacovigilance (DQPPV)

This leading pharmaceutical group has operations in South Dublin and the UK and are focussed on the development and commercialisation of speciality products and other high-value niche products. Due to growth, there is an opportunity for an experienced Pharmacovigilance professional to join their team on an initial 12 month fixed term contract. This person will act as Deputy Qualified Person for Pharmacovigilance (DQPPV).

The Role

Reporting into the QPPV you will be based in Dublin and work cross-functionally with RA, Quality and Artworks and also liaise with the manufacturing site in the UK. There are new products under development which will add to our clients impressive portfolio of products.

Main responsibilities include but are not limited to the following:

  • Assist the QPPV in maintaining the Pharmacovigilance systems in line with the requirements for human and veterinary pharmaceutical products
  • Assist the QPPV in maintaining an overview of the safety profiles of the company’s medicinal products and any emerging safety concerns
  • In the absence of the QPPV, act as the single point of contact for PV
  • Respond to requests for information from the Competent Authorities relating to the safety profile of the company products or PV activities
  • Assist the QPPV in maintaining the Pharmacovigilance System Master File (PSMF) and the Detailed Description of the Pharmacovigilance System (DDPS) for human and veterinary products respectively
  • Prepare Adverse Drug Reaction (ADR) reports and expedite reports to Competent Authority when required
  • Conduct periodic ICSR reconciliation with business partners
  • Generation and management of aggregate reports such as line listings and summary tabulations
  • Signal management activities including signal detection and validation
  • Compile and present signal detection and periodic PV reports
  • Prepare annual schedule for Periodic Safety Update Reports (PSURs)
  • Prepare, review and assist in submission of PSURs
  • Prepare, review and submit Risk Management Plans
  • Prepare and maintain Safety Data Exchange Agreements and Technical Agreements

The Person

You must possess the following to be considered:

  • A BSc or MSc in Science or related
  • 5 years’ experience in Pharmacovigilance / Drug Safety
  • Previous experience within Medical Information desirable
  • Demonstrated planning and organisation skills
  • Ability to work autonomously, effectively and collaboratively
  • Excellent interpersonal and negotiation skills (internal/external)
  • Eligible to live and work in the EU

The Benefits

  • Excellent career and professional development opportunities
  • Competitive salary
  • Completion bonus
  • Flexible working hours and work from home options

To discover more about this opportunity, apply now or contact Gillian McMurrough at HRM on + 353 1 6321827 for a confidential discussion.

Salary: €60000 - €65000 Location: Dublin South